Chuangjian Medical obtains US GRAS certification

Under the national anti-aging trend, consumers are also paying more and more attention to all-round anti-aging from the inside out, and oral beauty products have ushered in a new development outlet. Among them, thanks to ingredient innovation and technological breakthroughs, collagen has become an indispensable "star ingredient" for oral beauty. In this field

 

Public information shows that GRAS (Generally Recognized as Safe) certification is a product safety certification method stipulated by the U.S. Food and Drug Administration (FDA). Only products that have undergone rigorous review and are unanimously recognized by an expert panel as meeting GRAS standards can obtain this certification.

 

Supporting documents on the use of recombinant collagen in food in accordance with the "Generally Recognized as Safe" (GRAS) standard

At the same time, GRAS certification is also a procedure established by the FDA to confirm the safety of certain food ingredients. These ingredients may be naturally occurring substances or artificially synthesized. Specifically, GRAS certification is mainly applicable to companies that plan to use a substance as a food ingredient or food additive, with the purpose of proving that the substance is safe for human health when used in accordance with the intended purpose and concentration.

 

GRAS Expert Group Conclusion: The recombinant collagen produced by Jiangsu Chuangjian Medical meets the food grade specifications and can be safely used as food and beverage ingredients

It is understood that GRAS certification is one of the most transparent and sound food regulatory methods in the world. Once a substance obtains GRAS certification, it can be used legally as a food additive without the need for a separate approval process by the FDA. It is worth mentioning that GRAS has a very high degree of recognition in North America and around the world, and is an important credential for new food ingredients to enter the international market.

It is reported that the requirements for obtaining GRAS certification are very strict. Companies need to provide reliable scientific data support to prove that the ingredient is safe for human health under its specific use. These data include clinical studies, toxicology studies, animal experiment results, or historical usage experience.

It can be seen that for Chuangjian Medical, its food-grade recombinant humanized type III collagen has obtained GRAS certification, which not only proves that the product meets the most stringent international safety standards, but also highly recognizes the safety and effectiveness of its products. It also ensures the legal use of the product in the global market.

Adding a new fire to the oral beauty and anti-aging market

It is worth noting that the food-grade recombinant humanized type III collagen under Chuangjian Medical has obtained GRAS certification, which also meets the huge demand of the current oral beauty and anti-aging market.

As we all know, when "Healthy China" was officially upgraded to a national strategy, the big health industry ushered in rapid development. The scale and number of health care product consumption have risen rapidly year by year, among which oral beauty has also become a new gold mine and has shown great development potential. Behind this trend is the current consumer's multiple demands for safety, health, anti-aging beauty and convenience. Especially in the domestic market, with the accelerated pace of life, consumers are more eager for food that combines nutritional supplements with lifestyle.

Compared with beauty products, the category of oral beauty products is relatively single. Brands can only break this limitation by launching more innovative products, and behind product innovation is the competition between ingredients and technology. In terms of ingredients, collagen is a popular ingredient in the current oral beauty and anti-aging track. For example, brands such as Shiseido, Mama mujer, and ZAHOO have also launched oral beauty products with collagen as the core ingredient, "to enhance skin elasticity and radiance."

Research data shows that the global collagen oral product market will reach US$4.5 billion in 2023 and is expected to reach approximately US$9.1 billion by 2032, with a compound annual growth rate of 8.21%

However, it is worth noting that the use of traditional animal collagen in food is very limited. The "White Paper on the Development of Domestic High-quality Collagen Industry" shows that traditional animal-derived collagen depends on animal tissues such as pigs, cattle, and fish, while collagen extracted from raw materials such as pigs and cattle generally has the following four problems: First, there are animal and poultry diseases, such as the risk of virus carrying such as foot-and-mouth disease, mad cow disease, avian influenza, and the risk of animal antibiotic residues; second, it has a certain immunogenicity, which is easy to cause the body's immune response, causing adverse reactions such as allergies, inflammation, and fever; third, there are religious taboos and ethical conflicts; fourth, collagen extracted from leather waste of cattle and pigs contains heavy metal Cr3+, which is difficult to remove with the existing extraction process, posing a food safety risk.

In addition, although the content of fish collagen is higher and the extraction cost is lower than that of pigs and cattle, it has the characteristics of low antigenicity and low allergy, and is safer. However, due to the increasingly serious problem of water pollution in recent years, the safety risks of fish collagen have also increased.

Therefore, overall, animal-derived collagen is limited by the scale of breeding, disease prevention and control, supply uncertainty and quality fluctuations, and it is difficult to meet the strict requirements of modern functional foods for safety.

The recombinant humanized type III collagen of Chuangjian Medical has solved the above problems better. Recently, Chuangjian Medical and the team of China Agricultural University published an academic paper entitled "Food Safety Evaluation of Recombinant Humanized Type III Collagen". The research follows the Chinese food safety standards and relevant OECD guidelines, covering genetic toxicity tests such as bacterial reverse mutation (Ames test), mouse sperm abnormalities, and micronuclei in mammals, as well as acute oral toxicity, 90-day subchronic toxicity, and embryo-fetal developmental toxicity studies.

 

 

Academic paper on comprehensive toxicological testing and allergy risk assessment of recombinant humanized type III collagen (RHTypeIII)

Data show that Chuangjian Medical's recombinant humanized type III collagen has no risk of genetic toxicity, no acute and subchronic toxicity, no adverse effects on embryos, and extremely low allergy risk, which confirms that Chuangjian Medical's recombinant humanized type III collagen has extremely high safety as a food ingredient.

Since its establishment in 2015, Chuangjian Medical has chosen the Pichia yeast expression system with relatively high technical barriers to prepare recombinant collagen that is more conducive to purification and safer, laying the foundation for subsequent diversified applications. The scientific and complete research plan and excellent experimental data and results have made Chuangjian Medical's recombinant humanized type III collagen as a food ingredient unanimously recognized by many authoritative experts in the American scientific community and obtained GRAS certification in one fell swoop.

It is understood that under the premise of ensuring safety, recombinant humanized collagen not only has high activity and high biocompatibility, but also has anti-aging effects such as improving skin elasticity, promoting collagen regeneration, and enhancing skin moisturizing ability. This not only means that Chuangjian Medical has successfully passed the "big test" of the world's most stringent food regulatory standards, but also means that Chuangjian Medical is expected to "add new fire" to the oral beauty and anti-aging track, which is in high demand.

According to investigations and research, recombinant humanized type III collagen can be used to prepare capsules, tablets, oral liquids, powders, soft candies and other product forms, and can play a wide range of roles in daily use scenarios.

Leading the green and sustainable development of the industry with synthetic biology manufacturing

Behind Chuangjian Medical's repeated "out-of-circle" is the company's meticulous cultivation in the field of synthetic biology.

Founded in 2015, Chuangjian Medical is a synthetic biology full-industry chain enterprise focusing on the research and development, production and sales of recombinant functional proteins and nucleic acids. For many years, its investment in technology research and development has exceeded 20% of its annual sales. Through continuous innovation in high-end biotechnology, Chuangjian Medical provides new raw materials for the medical, beauty, personal care and nutrition markets. In 2023, its recombinant collagen raw materials will rank first in global sales.

The recombinant collagen products prepared by Chuangjian Medical using synthetic biology technology not only have the advantages of high molecular purity, no virus-carrying risk, and extremely low cytotoxicity and immunogenicity. At the end of 2024, Chuangjian Medical will take the lead in undertaking the key project "New Non-toxic Cross-linked Recombinant Collagen Gel Soft Tissue Wound Repair Material" of the National Key R&D Program "Diagnostic Equipment and Biomedical Materials", aiming to solve the clinical problems of viral infection, allergy or rejection of traditional animal-derived tissue repair dermal scaffolds through key core technologies of biomedical materials.

Synthetic biology technology also has the characteristics of resource conservation, renewable raw materials, clean and efficient processes, and environmental friendliness. It has a shorter production cycle, higher production capacity, low carbon emissions, and avoids the consumption of natural resources in the breeding process of traditional aquaculture, bringing a new round of subversive industrial transformation and upgrading around the world.

In other words, as a leading recombinant collagen company, Chuangjian Medical has achieved the green preparation and industrial production of recombinant collagen through biofermentation technology. Its raw materials are environmentally friendly and recyclable, reducing the waste of resources and providing green and low-carbon products without animal ingredients to global customers. This is also highly consistent with the current concept of healthy and sustainable consumption.

It is worth mentioning that in 2023, Chuangjian's recombinant collagen products also obtained Intertek's "Green Leaf Certification". At the 2024 Third International Green Zero Carbon Festival and 2024ESG Leaders Summit, Chuangjian Medical also won the "2024 Green Sustainable Development Contribution Award" for its green and low-carbon development and outstanding performance in the ESG field, and Chairman Qian Song won the "2024 Green Development Driving Force Person".

It is reported that in recent years, Chuangjian Medical has actively deployed overseas markets, and its dealer network covers more than ten countries including North America, South America, Europe, and Asia. It has obtained 9 PCT international patent authorizations and is the first synthetic biology company in the field of recombinant collagen in China to obtain Ecovadis Bronze Certification and Intertek Carbon Footprint Certification.

There is no doubt that the GRAS certification this time is an important milestone in the diversified application and international market expansion of Chuangjian Medical's recombinant collagen, laying the foundation for its development of oral beauty and anti-aging tracks and accelerating the internationalization process. It is foreseeable that, driven by factors such as the country's strong policy support for the field of biomaterials, the rapid development of synthetic biotechnology and the strong demand in the oral beauty market, Chuangjian Medical's recombinant collagen oral beauty products will also be launched in the near future and set off a new wave in the industry.